Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT04764656
Status:
TERMINATED
Last Update Posted:
2025-03-25
First Post:
2021-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for Neovascular Age-related Macular Degeneration (nAMD) in Portugal
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated earlier since the obtained sample was not representative of the Portuguese population, and pointed to the high fragility in evaluating the data, making it difficult to carry out a statistical study and draw valid conclusions.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLUESKY-PT
Brief Summary:
This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.
Detailed Description:
Naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given.
The baseline visit will be used to assess eligibility and collect baseline characteristics information. The study eye will be defined as the first eye treated during the study; the other eye will be considered as fellow eye. If both eyes are treated at baseline, the eye with the worse visual acuity will be chosen as the study eye (if the visual acuity is measured equal, the treating ophthalmologist defines the study eye upon his discretion). The follow-up visits will take place at a frequency defined as per investigator's discretion. Patients that have not received an intravitreal anti-VEGF injection or visited an eye specialist for at least 6 months will be discontinued from the observation.
Retrospective data will be collected for switch patients starting treatment with brolucizumab for up to six months before baseline. Patients, already being treated with brolucizumab may also be included. Here, retrospective data will be collected since the first brolucizumab injection.
The baseline visit will be used to assess eligibility and collect baseline characteristics information. The study eye will be defined as the first eye treated during the study; the other eye will be considered as fellow eye. If both eyes are treated at baseline, the eye with the worse visual acuity will be chosen as the study eye (if the visual acuity is measured equal, the treating ophthalmologist defines the study eye upon his discretion). The follow-up visits will take place at a frequency defined as per investigator's discretion. Patients that have not received an intravitreal anti-VEGF injection or visited an eye specialist for at least 6 months will be discontinued from the observation.
Retrospective data will be collected for switch patients starting treatment with brolucizumab for up to six months before baseline. Patients, already being treated with brolucizumab may also be included. Here, retrospective data will be collected since the first brolucizumab injection.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: